Senior Process Engineer
2 weeks ago
About Civica Rx:
Civica Rx is a 501(c)(4) social welfare organization founded to address the critical shortages of generic injectable medications that impact patient care across the United States. With over 300 essential medications currently in shortage, Civica Rx aims to mitigate these challenges through innovative solutions and strategic partnerships.
Our organization was established by a coalition of health systems and philanthropic foundations, bringing together expertise from leading healthcare providers to ensure that patients receive the medications they need at affordable prices. Civica Rx has expanded its mission to include lowering costs at the pharmacy counter and has launched initiatives to develop and deliver affordable biosimilar insulin.
Job Overview:
The Senior Process Engineer will be instrumental in preparing the Civica Petersburg facility for production and will oversee the design and implementation of systems for a new biologics expansion. This role involves working on a high-speed cartridge filling line and enhancing critical utility services while ensuring compliance with Good Manufacturing Practices (GMP).
Reporting to the Director of Engineering, Insulin, the Senior Process Engineer will collaborate closely with teams across Research & Development, Manufacturing Sciences & Technology (MSAT), and Quality Assurance to develop and refine technical transfer processes that align with business objectives.
Key Responsibilities:
- Engage in hands-on work within a collaborative team environment.
- Provide technical guidance on Commissioning, Qualification, and Validation (CQV) activities, ensuring adherence to regulatory standards and engineering best practices.
- Contribute to the engineering process by establishing technical and procedural controls in process design, including scale-up considerations.
- Lead CQV activities for assigned systems, encompassing user requirements, validation planning, protocol generation, and system release.
- Deliver engineering outputs in a timely manner, proactively addressing potential risks to ensure project milestones are met.
- Identify and address operational gaps to facilitate a seamless transition to manufacturing operations.
- Collaborate with cross-functional teams to troubleshoot technical issues and drive continuous improvement initiatives.
- Document control strategies and ensure that manufacturing batch records align with established conditions.
- Provide ongoing technical support to manufacturing teams throughout various operational stages.
Qualifications:
- Bachelor's degree in Pharmaceutical Sciences, Engineering, or a related technical field; advanced degrees are preferred.
- A minimum of 6 years of relevant industry experience, particularly in sterile fill-finish processes and biologics.
- Strong mechanical aptitude and familiarity with FDA regulations.
- Proven problem-solving skills and the ability to manage multiple complex projects in a fast-paced environment.
- Excellent communication skills and the ability to work effectively with diverse teams.
- Willingness to adapt to changing project demands.
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